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FDA 510(k)

F055 B.O. FANTASTIC RELAXER

K-Number: K914707 · 1991-12-09

ApplicantFairform Mfg., Co., Ltd.
Decision Date1991-12-09
Product CodeIRO
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

F055 B.O. FANTASTIC RELAXER is the device name listed in this FDA 510(k) record. The listed applicant is Fairform Mfg., Co., Ltd.. It received FDA 510(k) clearance on 1991-12-09 under 510(k) number K914707. The device is classified under product code IRO. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the F055 B.O. FANTASTIC RELAXER?

F055 B.O. FANTASTIC RELAXER is a medical device that received FDA 510(k) clearance on 1991-12-09. The listed applicant is Fairform Mfg., Co., Ltd.. The 510(k) number is K914707.

When did F055 B.O. FANTASTIC RELAXER receive FDA 510(k) clearance?

F055 B.O. FANTASTIC RELAXER received FDA 510(k) clearance on 1991-12-09, under 510(k) number K914707.

Who is the listed applicant for F055 B.O. FANTASTIC RELAXER?

The FDA 510(k) record lists Fairform Mfg., Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for F055 B.O. FANTASTIC RELAXER?

The FDA product code for F055 B.O. FANTASTIC RELAXER is IRO.

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Other records listing Fairform Mfg., Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K931640AO11 BODY MASSAGERK931638FO96 HANDY MASSAGERK931637A013 FEMI-FORM FACIAL MASSAGERK931639F183 AC-MINI MASSAGER WITH UL APROVED ADAPTORK931636FO18/FO98 SCRUBOFLEX SHOWERPROOF BRUSH MASSAGERK920644F499 DELUXE ELECTRIC TOOTH BRUSH W/ STAND

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Related Devices (Code: IRO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K955160COMFORT, MUSCLE, CORDLESS MASSAGER, BATTERY POWERED OPERATED MASSAGEREverapex Design & Marketing Corp.K955250QI GONG MASSAGEREast Health Development Group, Inc.K954203MASSAGER THERAPUTIC, ELECTRICCisco Sales Corp.K952916SHIATSU MASTER MASSAGER CUSHIONKinsei Shiatsu, Inc.K951414CHAMPION PHYSIOACOUSTICC RECLINER-TRANSPORTER CHAIRChampion Mfg. Corp.K950441CONAIR FAMILY FITNESS BODY ENERGYConair Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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